CPS DIRECT SL OUTER CATHETER

Catheter, Percutaneous

ST. JUDE MEDICAL

The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Cps Direct Sl Outer Catheter.

Pre-market Notification Details

Device IDK053277
510k NumberK053277
Device Name:CPS DIRECT SL OUTER CATHETER
ClassificationCatheter, Percutaneous
Applicant ST. JUDE MEDICAL 15900 VALLEY VIEW CT. Sylmar,  CA  91342 -3577
ContactDeanna Hughes
CorrespondentDeanna Hughes
ST. JUDE MEDICAL 15900 VALLEY VIEW CT. Sylmar,  CA  91342 -3577
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-11-23
Decision Date2006-02-24
Summary:summary

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